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This interactive course with workshops is designed to bring you up-to-date with regulatory requirements regarding Quality and Technical Agreements. You get to know a practical approach, applicable for contract givers and acceptors, to establish, implement and update these agreements.
Audience
Functions involved in the establishment, implementation and updating of Quality and Technical Agreements or auditing of implemented arrangements
Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 12:00
Course
10:00 - 10:30
Networking & closing
Price
€ 799
per participant (excl. VAT)
✓ Exclusive learning approach
✓ Personal course documentation
✓ Lunch, water, coffee & tea
✓ Networking
✓ Course certificate after completion
Location
Quastion Learning Center (Qplus consult BVBA)
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
Your Trainer
Kristina Bindus
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Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.
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Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.
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Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.
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Kristina is specialized in online medical communication: webcast, webinar and e-learning.
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She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.
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Kristina has an extensive experience in Quality & Pharmacovigilance.
- Kristina Bindus has over 25 years of experience in QA, RA, Auditing and Pharmacovigilance within leading (bio)pharmaceutical and medical devices companies.
Program
Roadmap for a practical Approach
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How to start and what do I need?
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Who is involved?
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Which activities require a Quality and Technical Agreement?
GMP and GDP Requirements
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Duties and responsibilities of contract giver and contract acceptor
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Outsourced activities
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Correctly defined, agreed and controller contracted services
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Suppliers
Structure & Content of Agreements
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How to create own template
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Role of QA and Qualified Person/Responsible Person for GDP
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Basic principles of contractual obligations and responsibilities
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Content of agreement
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Definitions
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Timelines and targets
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Service/commercial agreements vs Quality and Technical Agreements
Common Pitfalls and how to avoid them
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Expectations of the Health Authorities
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The most common pitfalls and tools to avoid them
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Implementation of the Quality and Technical Agreement arrangements into your own quality system
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How to evaluate and document your compliance to the agreed arrangements
Duties and Responsibilities of Contract Giver and Contract Acceptor
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Quality and Technical Agreement
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Quastion Learning Center
Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium
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